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Boehringer Ingelheim accelerates precision oncology research with initiation of three Phase III trials in hard-to-treat cancers

On June 22, 2026 Boehringer Ingelheim reported it is advancing biomarker-informed approaches and extending precision care across multiple cancers and stages of disease, reinforcing its ambition to bring unprecedented impact and improve long-term outcomes where unmet need remains high. The company has initiated two Phase III clinical trials within the DAREON program: DAREON-Lung-1 in small cell lung cancer (SCLC) and DAREON-NEC-1 in extrapulmonary neuroendocrine carcinoma (epNEC). In parallel, the Phase III Beamion LUNG-3 trial has been initiated in HER2 (ERBB2)-mutant non-small cell lung cancer (NSCLC).

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"People living with aggressive cancers often face a shortage of treatment choices," said Lykke Hinsch Gylvin, MD, Chief Medical Officer, Boehringer Ingelheim. "With the launch of these trials, we are advancing our precision oncology ambitions to move targeted therapies into earlier treatment lines and bring biomarker-informed science into late-stage development. By focusing on the biology of each tumor, we aim to give patients facing cancer more precise treatment options with the goal of improving outcomes where the need is greatest."

Biomarker-informed approaches: DLL3
The two DAREON Phase III trials mark a pivotal step for obrixtamig, Boehringer’s investigational DLL3/CD3 T-cell engager, and for the company’s broader biomarker strategy in aggressive neuroendocrine carcinomas (NECs) such as SCLC and epNEC. People with SCLC, the most aggressive type of lung cancer, often face short-lived therapeutic benefit and poor survival with existing approaches.5,7 EpNEC is a historically under-researched cancer for which survival outcomes have not improved in decades. For those living with these cancers, treatment options are limited and significant unmet needs persist.1,8

Delta-like canonical Notch ligand 3 is expressed on tumor cells in SCLC and epNEC while largely absent from non-cancerous cells. This makes it a potential predictive biomarker that could help to redefine treatment strategies for these aggressive cancers.9,10 DAREON-Lung-1 and DAREON-NEC-1 are designed to test whether the addition of obrixtamig, a DLL3 targeted T-cell engager, can improve outcomes in biomarker-informed patient populations versus the current standard of care.1,2 Together, the studies aim to position obrixtamig as part of a broader shift toward more personalized and potentially more transformative treatment approaches in these aggressive NECs.

Precision oncology in earlier stages: HER2
In addition, the company is investigating zongertinib in earlier stages of disease with the initiation of Beamion LUNG-3. This global, randomized Phase III trial will study the efficacy and safety of zongertinib as adjuvant monotherapy compared with physician’s choice standard of care in patients with stage II-IIIB HER2 (ERBB2)-mutant NSCLC who have undergone complete surgical resection and have received either neoadjuvant or adjuvant therapy.3 The study is designed to evaluate whether zongertinib can improve disease-free survival compared to standard of care following surgery, addressing the significant risk of recurrence after curative-intent treatment.11 Beamion LUNG-3 reflects the company’s focus on advancing targeted therapies earlier in the treatment pathway, where effective targeted adjuvant treatment options are not available.12 This trial extends the investigation of zongertinib to early stage disease.3

Expanding the oncology portfolio
Boehringer Ingelheim continues to expand its portfolio of precision oncology approaches that combine targeted therapies for biomarker-defined populations with innovative strategies to both activate and direct the immune system. This includes next-generation immunotherapies such as T-cell engagers, alongside complementary modalities that aim to enhance anti-tumor responses and address tumor-intrinsic drivers of disease. By integrating these approaches, the company aims to expand treatment options for people facing cancers with high unmet medical need.

About obrixtamig
Obrixtamig is an investigational novel Immunoglobin G (IgG)-like bispecific T-cell engager designed to bind concomitantly to DLL3 on tumor cells and CD3 on T-cells, potentially resulting in destruction of tumor cells by the body’s own immune system. Obrixtamig is being evaluated in multiple, ongoing clinical trials, including a Phase I trial in combination with atezolizumab and chemotherapy in extensive-stage small-cell lung cancer (ES-SCLC) patients (DAREON-8), a Phase Ib study to investigate obrixtamig in combination with the current SoC (carboplatin + etoposide) as 1L treatment for patients with DLL3-positive NEC, including epNEC (DAREON-7), and a Phase II trial in patients with relapsed/refractory DLL3-high extrapulmonary neuroendocrine carcinomas (epNEC) (DAREON-5).12,13,14 The Phase III clinical development program includes DAREON-LUNG-1, which evaluates obrixtamig in combination with atezolizumab plus chemotherapy vs. atezolizumab plus chemotherapy for first-line use in patients with ES-SCLC.1 In addition, DAREON-NEC-1 is evaluating obrixtamig in combination with current SoC (carboplatin and etoposide) vs. SoC alone as first-line therapy in patients with DLL3-positive unresectable locally advanced or metastatic epNEC.2

In order to tackle hard-to-treat cancers, Boehringer is drawing on innovation enabled through collaboration. The company is developing obrixtamig through a long-term partnership with Oxford BioTherapeutics (OBT), using OBT’s OGAP platform to identify novel target opportunities for new immunotherapies harnessing its investigational T-cell engager, investigational cancer vaccine and exploratory oncolytic virus platforms.

About zongertinib
Zongertinib is an irreversible tyrosine kinase inhibitor (TKI) that selectively inhibits HER2 while sparing wild-type EGFR, thereby minimizing associated toxicities.16,17 Zongertinib is approved in the U.S., China, Hong Kong and Japan as the first once-daily orally administered targeted therapy for adult patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer. Zongertinib is not approved in other markets.

The treatment is being evaluated in ongoing trials across a range of earlier stages and advanced solid tumors with HER2 alterations. Beamion LUNG-2 is an ongoing Phase III controlled study evaluating zongertinib as a first-line treatment for patients with advanced NSCLC that has HER2 tyrosine kinase domain mutations (NCT06151574).18 Beamion LUNG-3 is a Phase III clinical trial investigating zongertinib as an adjuvant monotherapy in patients with early-stage, resectable NSCLC (Stage II-IIIB) with HER2 (ERBB2)-mutations (NCT07195695).

(Press release, Boehringer Ingelheim, JUN 22, 2026, View Source [SID1234668862])

Exelixis Provides Update on the Phase 3 STELLAR-303 Trial Evaluating Zanzalintinib in Combination with an Immune Checkpoint Inhibitor in Patients with Metastatic Colorectal Cancer

On June 22, 2026 Exelixis, Inc. (Nasdaq: EXEL) reported results from the final analysis of the dual primary endpoint of overall survival (OS) in the subset of patients without active liver metastases (non-liver metastases, NLM) in the phase 3 STELLAR-303 pivotal trial evaluating zanzalintinib in combination with atezolizumab (Tecentriq) versus regorafenib in previously treated non-microsatellite instability (MSI)-high metastatic colorectal cancer (mCRC). The results showed a non-statistically significant trend in OS favoring the combination in the NLM subpopulation (stratified hazard ratio: 0.83; 95% confidence interval: 0.66–1.05; P=0.1185), with median OS values of 15.9 months with zanzalintinib in combination with atezolizumab, and 12.7 months with regorafenib.

The safety profile of zanzalintinib in combination with atezolizumab in the NLM subgroup was consistent with that previously reported in the intention-to-treat (ITT) population, and no new safety signals were identified.

Exelixis previously announced that STELLAR-303 met its other dual primary endpoint, demonstrating a statistically significant improvement in OS in the ITT population, which included all randomized patients regardless of the presence of active liver metastases. Detailed results demonstrating the statistically significant improvement in OS in the ITT population were presented at the 2025 European Society for Medical Oncology Congress and published in The Lancet.

In February 2026, Exelixis announced that the U.S. Food and Drug Administration (FDA) accepted the company’s New Drug Application (NDA) for zanzalintinib, in combination with atezolizumab, for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, and, if RAS wild-type, an anti-epidermal growth factor receptor (EGFR) therapy. The FDA assigned a Prescription Drug User Fee Act target action date of December 3, 2026.

Detailed findings from the NLM subgroup analysis will be submitted for presentation at an upcoming medical conference.

About STELLAR-303
STELLAR-303 (NCT05425940) is a global, multicenter, randomized, phase 3, open-label study that randomized patients 1:1 to either zanzalintinib in combination with atezolizumab (n=451) or regorafenib (n=450). The study includes patients with previously treated non-MSI-high mCRC. The dual primary endpoints of the study are OS in the ITT population and in the NLM subgroup of patients. The ITT population consisted of all randomized patients, regardless of the presence of liver metastases. The NLM subgroup consisted of patients who did not have active liver metastases at baseline as determined by investigator assessment. Secondary endpoints include progression-free survival, objective response rate and duration of response in the ITT population and in the NLM subgroup of patients. More information about the trial is available at ClinicalTrials.gov.

About Zanzalintinib
Zanzalintinib is a novel oral kinase inhibitor that inhibits the activity of the TAM kinases (TYRO3, AXL, MER), MET and VEGF receptors. These kinases play important roles in oncogenic processes, including tumor cell proliferation, metastasis, angiogenesis, drug resistance and evasion of antitumor immunity. The zanzalintinib development program includes a series of ongoing and planned pivotal trials to explore its therapeutic potential in CRC, clear cell and non-clear cell renal cell carcinoma, and neuroendocrine tumors, as well as earlier-stage trials in meningioma, lung cancer and castration-resistant prostate cancer.

Zanzalintinib is an investigational agent that is not approved for any use and is the subject of ongoing clinical trials.

About CRC
CRC is the third most common cancer and a leading cause of cancer-related deaths in the U.S.1 Approximately 159,000 new cases will be diagnosed in the U.S. in 2026, with around 55,000 expected deaths from the disease.1 CRC is most frequently diagnosed among people aged 65-74 and is more common in men and in people of non-Hispanic American Indian/Alaska Native descent.2 Nearly a quarter of CRC cases are diagnosed at the metastatic stage, at which point the five-year survival rate is around just 15%.1,2 The liver is the most common site for CRC metastasis. Liver metastases significantly impact survival, with a median five-year survival rate of less than 14% when treated with palliative chemotherapy.

(Press release, Exelixis, JUN 22, 2026, View Source [SID1234668861])

TScan Therapeutics Announces Positive Initial Data from Cohort C of Ongoing ALLOHA™ Phase 1 Study Evaluating TSC-101 in Patients with Heme Malignancies Undergoing Allogeneic Hematopoietic Cell Transplantation

On June 22, 2026 TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, reported data from Cohort C of the ongoing ALLOHA Phase 1 study, evaluating TSC-101 generated with the commercial-ready manufacturing process, in patients with heme malignancies undergoing allogeneic hematopoietic cell transplantation (allo-HCT).

"These data provide important support for our commercial-ready manufacturing process and reinforce our confidence in the consistency and quality of the product candidate being delivered to patients," said Gavin MacBeath, Ph.D., Chief Executive Officer. "We are very encouraged by the 11 of 14 patients who showed complete donor chimerism approximately three weeks after their first infusion as well as the complete chimerism seen in all 5 patients who were assessed after their second infusion of TSC-101. Furthermore, even in a higher-risk patient population when compared to patients in Cohort A and our control arm, 93% of patients responded to TSC-101 with decreasing recipient chimerism. Taken together, these findings support our planned transition into the pivotal Phase 3 study of TSC-101 this month. We look forward to advancing further development of TSC-101 with the goal of preventing relapse following allo-HCT and improving outcomes for these patients."

"The initial results from Cohort C continue to exhibit strong clinical efficacy while maintaining a positive safety profile in patients receiving TSC-101 after their standard of care allo-HCT," said Chrystal U. Louis, M.D., Chief Medical Officer. "This cohort enrolled ahead of schedule and highlights the strong investigator engagement and growing interest in the TSC-101 clinical development program. As relapse remains a leading cause of death following allo-HCT, we are encouraged by the potential of TSC-101 to address residual disease and thereby improve long-term outcomes for patients with heme disorders."

Key Data Highlights

•
19 patients were enrolled in Cohort C:

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~90% manufacturing success rate (17/19) with commercial-ready process

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14/19 patients went to transplant and received their first infusion of TSC-101

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10/14 patients have received their planned second infusion, and 1/14 patients received a third infusion

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3/19 patients did not proceed to transplant due to clinical reasons

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Chimerism data as observed by high sensitivity NGS assay (Alloheme) with assay cut-off of 0.2%:

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11 of 14 patients achieved complete donor chimerism within ~3 weeks of receiving their first infusion of TSC-101 and 2 of the remaining 3 patients are approaching complete donor chimerism

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One patient with TP53 mutated AML remained in complete donor chimerism 6 months post-HCT

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TSC-101 infusions were generally well-tolerated, safety was consistent with Cohort A, and observed adverse events were consistent with post-HCT adverse events.

Virtual Key Opinion Leader (KOL) Event

The Company will host a virtual KOL event featuring Ran Reshef, M.D., M.Sc., today, June 22, 2026, at 8:30 a.m. ET to discuss initial data from Cohort C of the ALLOHA Phase 1 study using its commercial-ready manufacturing process, as well as plans and expectations for initiating a pivotal Phase 3 study for TSC-101. The Company will also discuss follow-on product candidates and the market opportunity for the heme program. A replay of the webcast will be available following the call.

(Press release, TScan Therapeutics, JUN 22, 2026, View Source [SID1234668858])

PharmaMar enrolls First Patient in Phase 1/2 Trial Evaluating PM54 Plus Pembrolizumab in Advanced Solid Tumors

On June 22, 2026 PharmaMar (MSE: PHM) reported the enrollment of the first patient in its Phase 1/2 clinical trial evaluating PM54 in combination with pembrolizumab for the treatment of patients with advanced-stage solid tumors. The study, for which the IND application was cleared by the FDA in December 2025, is designed to assess the safety, tolerability, and preliminary efficacy of this combination therapy in patients with previously treated advanced malignancies.

The primary objectives of the study include the evaluation of the safety and tolerability of PM54 in combination with pembrolizumab and to establish the recommended dose, as well as the assessment of the antitumor activity, in terms of clinical benefit rate (CBR) and objective response rate (ORR) based on investigator evaluation. The study includes patients with tumors characterized by significant unmet medical needs, including advanced-stage melanoma, endometrial cancer, extrapulmonary neuroendocrine tumors and mesothelioma.

For more information on the study, please visit clinicaltrials.gov

PM54 in combination with pembrolizumab is intended to enhance antitumor immune responses and provide a potential new treatment option for patients with advanced-stage solid tumors.

(Press release, PharmaMar, JUN 22, 2026, View Source [SID1234668856])

Ligand Announces Proposed Offering of $550 Million of Convertible Senior Notes Due 2031

On June 22, 2026 Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) ("Ligand") reported its intention to offer $550.0 million aggregate principal amount of convertible senior notes due 2031 (the "notes") in a private placement (the "offering") to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act"), subject to market conditions and other factors. Ligand also expects to grant to the initial purchasers of the notes (the "initial purchasers") a 13-day option to purchase up to an additional $82.5 million aggregate principal amount of notes.

Key Elements of the Transaction

The notes will be general unsecured, senior obligations of Ligand and will accrue interest payable semiannually in arrears on March 15 and September 15 of each year, beginning on March 15, 2027. The notes will mature on September 15, 2031, unless earlier converted, redeemed or repurchased. Upon conversion of the notes, Ligand will pay cash up to the aggregate principal amount of the notes to be converted and pay or deliver, as the case may be, cash, shares of Ligand’s common stock or a combination of cash and shares of Ligand’s common stock, at Ligand’s election, in respect of the remainder, if any, of Ligand’s conversion obligation in excess of the aggregate principal amount of the notes being converted. The interest rate, initial conversion rate, redemption or repurchase rights and other terms of the notes will be determined at the time of pricing of the offering.

Use of Proceeds

Ligand expects to use a portion of the net proceeds from the offering to pay the cost of the convertible note hedge transactions described below (after such cost is partially offset by the proceeds to Ligand from the sale of the warrants in the warrant transactions described below). In addition, Ligand expects to use up to $75 million of the net proceeds from the offering to repurchase shares of its common stock from certain purchasers of the notes in privately negotiated transactions, as described below. Ligand intends to use the remaining net proceeds from the offering for general corporate purposes including investing in complementary businesses, companies, products and technologies, although Ligand has no present commitments or agreements to do so beyond its previously announced agreement to acquire Xoma Royalty Corporation. If the initial purchasers exercise their option to purchase additional notes, Ligand expects to sell additional warrants to the option counterparties and use a portion of the net proceeds from the sale of the additional notes, together with the proceeds from the sale of the additional warrants, to enter into additional convertible note hedge transactions and the remaining net proceeds for general corporate purposes.

Convertible Note Hedge Transactions

In connection with the pricing of the notes, Ligand expects to enter into convertible note hedge transactions (the "convertible note hedge transactions") with one or more of the initial purchasers or their respective affiliates and/or other financial institutions (the "option counterparties"). Ligand also expects to enter into warrant transactions (the "warrant transactions") with the option counterparties, pursuant to which Ligand will issue warrants to purchase common stock (the "warrants") to such option counterparties. The convertible note hedge transactions are expected generally to reduce the potential dilution to Ligand’s common stock upon any conversion of notes and/or offset any cash payments Ligand is required to make in excess of the principal amount of converted notes, as the case may be. However, the warrant transactions could separately have a dilutive effect on Ligand’s common stock to the extent that the market price per share of common stock exceeds the strike price of the warrants. If the initial purchasers exercise their option to purchase additional notes, Ligand expects to enter into additional convertible note hedge transactions and additional warrant transactions with the option counterparties.

In connection with establishing their initial hedges of the convertible note hedge transactions and the warrant transactions, Ligand expects the option counterparties or their respective affiliates to enter into various derivative transactions with respect to Ligand’s common stock and/or purchase shares of Ligand’s common stock concurrently with or shortly after the pricing of the notes. This activity could increase (or reduce the size of any decrease in) the market price of Ligand’s common stock or the notes at that time.

The option counterparties or their respective affiliates may modify their hedge positions by entering into or unwinding various derivatives with respect to Ligand’s common stock and/or purchasing or selling shares of Ligand’s common stock or other securities of Ligand in secondary market transactions following the pricing of the notes and prior to the maturity of the notes (and are likely to do so in connection with any conversion, redemption or repurchase of the notes). This activity could also cause or avoid an increase or a decrease in the market price of Ligand’s common stock or the notes, which could affect a holder’s ability to convert its notes and, to the extent the activity occurs during any observation period related to a conversion of notes, it could affect the number of shares of Ligand’s common stock, if any, and value of the consideration, if any, that a holder will receive upon conversion of its notes.

Share Repurchases

In addition, Ligand expects to use up to $75 million of the net proceeds from the offering to repurchase shares of its common stock from certain purchasers of the notes in privately negotiated transactions effected through one of the initial purchasers or an affiliate thereof concurrently with the pricing of the notes. The price per share of Ligand’s common stock repurchased in such transactions is expected to equal the last reported price per share of Ligand’s common stock as of the date of the pricing of the notes. These repurchases could increase (or reduce the size of any decrease in) the market price of Ligand’s common stock prior to, concurrently with or shortly after the pricing of the notes, and could result in a higher effective conversion price for the notes. Ligand cannot predict the magnitude of such market activity or the overall effect it will have on the market price of the notes and/or the market price of Ligand’s common stock.

The notes and the warrants will only be offered to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act. The notes, the warrants, the shares of common stock into which the notes are convertible and the shares of common stock issuable upon exercise of the warrants have not been, and will not be, registered under the Securities Act or the securities laws of any other jurisdiction, and unless so registered, may not be offered or sold in the United States or to, or for the account or benefit of, U.S. persons, absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and other applicable securities laws.

This press release is neither an offer to sell nor a solicitation of an offer to buy any securities, nor shall it constitute an offer to sell, solicitation of an offer to buy or sale of any securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Ligand, JUN 22, 2026, View Source [SID1234668854])